In various instances, it may be desired to dispense products, such as products that are regulated by a governmental agency, for example, certain foods, pharmaceutical drugs, medical devices, radiation-emitting products, vaccines, cosmetics, and/or tobacco products, in a controlled manner. To this end, numerous devices have been proposed that provide controlled dispensing of such products. See, for example, the various medication dispensing devices described in U.S. Pat. No. 5,713,485 to Liff et al., U.S. Pat. No. 7,139,639 to Broussard et al., U.S. Pat. No. 8,423,181 to Hallin, U.S. Pat. No. 8,554,365 to Thomas et al., and U.S. Pat. No. 8,588,964 to Garda et al., and the timed cigarette dispenser described in U.S. Pat. No. 6,125,082 to Reid, all of which are incorporated herein by reference in their entireties.
Some of these products may be administered according to a prescription, which designates the user and a prescription schedule. Other products may be the subject of a clinical study in conjunction with the use and/or manufacturing of the product. In certain applications, clinical studies are designed to investigate whether the product is safe for use by the general public. In other applications, clinical studies are used to determine the effectiveness and/or results of the consumption of the product. In any event, clinical studies are typically conducted under strict clinical study protocols that describe specific parameters surrounding the studies. Such parameters may include, for example, the identity or designation of a clinical study participant, the timing of consumption of the product, and the type of data that will be collected during the clinical study. In many instances, the data collected during the clinical study may include data collected directly from a clinical study participant in the form of answers to one or more questions relating to the product and/or the clinical trial study participant's experience with the product.
In many cases, the effectiveness of a product, or the efficacy of a clinical study relating to a product, may be dependent upon strict adherence to the prescription or the clinical study protocol. This may include, for example, verifying that the properly designed user uses the product and/or controlling use of the product according to the schedule. To this end, devices have been proposed that monitor the administering of such products. See, for example, the unit dose medication compliance device described in U.S. Pat. No. 6,973,371 to Benouali, and the portable pill dispenser described in U.S. Patent Application Publication No. 2016/0287480 to Hancock et al., both of which are incorporated herein by reference in their entireties.
It would be desirable, however, to provide further control, monitoring, and data gathering relating to the use of such products. For example, in the case of a product that is the subject of the clinical study, it is often advantageous to collect data from the study participant at pre-set checkpoints during the study. Many clinical studies, however, are conducted over a relatively lengthy period of time, and it is not reasonable to confine a clinical study participant to a single location in a controlled environment. As such, these clinical studies rely on the study participant taking responsibility for following the study protocol and remembering to submit answers to questions relating to the study participant's experience with the product at the specified checkpoints called out in the protocol. There is a need, therefore, for a clinical study product dispensing device that addresses at least some of these issues.